The present invention relates to an oral administration unit containing the active substances Tramadol and Diclofenac and/or their respective physiologically compatible salts, the two active substances being present in subunits separately formulated in each case, in the same administration unit.
Tramadol is an analgesic used to treat severe and moderately severe pain, whose mode of action is not based on a pure opioid mechanism. Tramadol also does not exhibit the characteristic side effects of an opioid. In some cases nausea is observed as an undesirable accompanying symptom.
Other known, non-opioid analgesics suitable for treating less severe pain include steroid-free analgesics such as Diclofenac-Na, acetylsalicylic acid or Ibuprofen.
Furthermore, for the treatment of moderate to severe pain it is recommended by the WHO to combine opioid analgesics with non-steroidal analgesics in order to produce a more effective pain relief and possibly reduce the necessary administration amounts.
European Patent EP-B-0 546 676 discloses for example that the combination of Tramadol-HCl with non-steroidal anti-inflammatories, such as for example Ibuprofen, in a composition ratio of 1:1 to 1:200 produces a synergistically enhanced analgesic action. Tramadol-HCl and Diclofenac-Na form a sparingly soluble compound however. It is therefore to be expected that the bioavailability of the two active substances is reduced and higher dosages are required in order to compensate for this.